NEW ORAL AIDS TEST |
Henahan, Access Excellence
Chicago, IL ( Jan. 14, 1997)
A bloodless HIV-antibody test using cells from the patient's
gums provides a highly accurate alternative to blood testing,
according to a study published in the Journal of the American
Medical Association (JAMA).
More than 3,500 patients seen at general medical and public
health clinics, blood banks, and clinics for HIV and other
sexually transmitted diseases participated in the study. The
sample consisted of 2,382 patients at low risk for HIV, 698 at
high risk, 242 with AIDS, and 248 with diseases associated with
increased frequency of false positive results in HIV testing.
The study measured the accuracy of the the new test, "the
OraSure System", by comparing results with true HIV-1 antibody
status. The results showed that the OraSure system provided the
correct result or would trigger appropriate follow-up testing in
more than 99.9% of the cases.
"Though we have known for 10 years that antibodies against
HIV-1 can be detected in the oral fluid of HIV-positive
subjects, this is the first reliable method for gathering and
testing oral samples," said John Fitchen, M.D., a lead
investigator and coauthor of the JAMA article.
"Our study demonstrates definitively that test results using
oral samples obtained with OraSure are highly accurate, and that
the system can be used in place of blood testing."
The Orasure technology uses a specimen called oral mucosal
transudate (OMT), not saliva. OMT is obtained using a specially
treated pad that is placed between the patient's gum and lower
cheek for two minutes. The pad is then placed in a preservative
and sent to a clinical laboratory where it is tested for the
presence of HIV antibodies, the same way blood samples are
tested. A single sample is sufficient for the initial screening
test and for confirmatory testing, if indicated.
Until now, the most accurate way to evaluate HIV status was to
obtain a blood sample. The new noninvasive method is considered
safer for both patients and health care workers.
The OraSure HIV-1 Western Blot Kit was cleared by the Food and
Drug Administration (FDA) last June, and is available from
"While the OraSure System is currently approved by the FDA for
administration by a trained healthcare professional under the
supervision of a physician, this technology may prove to be well
suited for use as a home test in the future," said Dr. Fitchen.
"Because it does not rely on a fingerstick or other means to
obtain a blood sample, OraSure should increase access to HIV
testing and therefore to counseling and early therapeutic
The research appeared in JAMA,
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